Implants And Procedures For Supporting Anatomical Structures For Treating Conditions Such As Pelvic Organ Prolapse

ABSTRACT

Implants for the treatment of pelvic support conditions and methods of implementing the same. The implants comprise relatively soft, flexible bodies and relatively strong arms extending in predetermined orientations therefrom. Methods and devices for placing the implants minimize trauma to the pelvic floor and provide well-anchored support to pelvic organs without interfering with sexual or other bodily functions.

RELATED APPLICATIONS

This application is a continuation of the U.S. patent application Ser.No. 15/136,616 filed Apr. 22, 2016 entitled Implants And Procedures ForSupporting Anatomical Structures For Treating Conditions Such As PelvicOrgan Prolapse, which is a continuation of the U.S. patent applicationSer. No. 14/286,953 filed May 23, 2014 entitled Implants And ProceduresFor Supporting Anatomical Structures For Treating Conditions Such AsPelvic Organ Prolapse, which is a divisional of U.S. patent applicationSer. No. 12/652,664 filed Jan. 5, 2010 entitled Implants And ProceduresFor Supporting Anatomical Structures For Treating Conditions Such AsPelvic Organ Prolapse, now U.S. Pat. No. 8,758,220, which claimspriority to U.S. Provisional Application Ser. No. 61/142,604 filed Jan.5, 2009, entitled Implantable Anchors For Use With Mesh Within The Body,and is related to U.S. application Ser. No. 12/652,640, filed Jan. 5,2010, entitled Implants And Procedures For Supporting AnatomicalStructures For Treating Conditions Such As Incontinence (now abandoned),and U.S. application Ser. No. 12/652,706, filed Jan. 5, 2010, entitledImplants And Procedures For Supporting Anatomical Structures (nowabandoned), all of which are hereby incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

The present invention pertains to the field of medical devices foranchoring and supporting anatomical structures and, more particularly,to implantable mesh that are operative to treat pelvic organ prolapseand incontinence.

BACKGROUND OF THE INVENTION

Pelvic floor disorders are a class of abnormalities that affect thepelvic region of millions of men and women. In women, for example, thepelvic region includes various anatomical structures such as the uterus,the rectum, the bladder, and the vagina. These anatomical structures aresupported and held in place by a complex collection of tissues, such asmuscles and ligaments. When these tissues are damaged, stretched, orotherwise weakened, the anatomical structures of the pelvic region shiftand in some cases protrude into other anatomical structures. Forexample, when the tissues between the bladder and the vagina weaken, thebladder may shift and protrude into the vagina, causing a pelvic floordisorder known as cystocele. Other pelvic floor disorders includevaginal prolapse, vaginal hernia, rectocele, enterocele, uterocele,and/or urethrocele.

Pelvic floor disorders often cause or exacerbate urinary incontinence(UI). One type of UI, called stress urinary incontinence (SUI), effectsprimarily women and is often caused by two conditions—intrinsicsphincter deficiency (ISD) and hypermobility. These conditions may occurindependently or in combination. In ISD, the urinary sphincter valve,located within the urethra, fails to close (or “coapt”) properly,causing urine to leak out of the urethra during stressful activity. Inhypermobility, the pelvic floor is distended, weakened, or damaged. Whenthe afflicted woman sneezes, coughs, or otherwise strains the pelvicregion, the bladderneck and proximal urethra rotate and descend. As aresult, the urethra does not close with sufficient response time, andurine leaks through the urethra.

UI and pelvic floor disorders, which are usually accompanied bysignificant pain and discomfort, are often treated by implanting asupportive sling or mesh in or near the pelvic floor region to supportthe fallen or shifted anatomical structures or more generally, tostrengthen the pelvic region by promoting tissue in-growth. Often,treatments of stress incontinence are made without treating the pelvicfloor disorders at all, potentially leading to an early recurrence ofthe stress incontinence.

Existing systems, methods, and kits for treatment typically employdelivery devices to position a supportive surgical implant into adesired position in the pelvic region. However, some of these systemsand methods require a medical operator to create multiple incisions anddeliver the implant using complex procedures. Moreover, many existingsurgical implants are not suitably sized or shaped to properly fitwithin a patient and treat pelvic floor disorders. Accordingly, medicaloperators and patients need improved systems, methods, and surgical kitsfor the treatment of pelvic floor disorders and/or urinary incontinence.

OBJECTS AND SUMMARY OF THE INVENTION

The present invention provides improved methods and devices forsupporting pelvic organs in the treatment of conditions such asincontinence and various pelvic floor disorders including but notlimited to cystocele, enterocele and rectocele.

Devices of the present invention include implants having soft, flexiblesupport bodies and anchors that are sturdy and durable.

Other devices of the present invention include introducers that allow animplant to be deeply implanted so as not to cause damage to the pelvicfloor and to preserve the natural length of the vagina.

Methods of the present invention include the use of multiple implantsfor treating multiple disorders, including treating pelvic floordisorders and incontinence.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects, features and advantages of which embodiments ofthe invention are capable of will be apparent and elucidated from thefollowing description of embodiments of the present invention, referencebeing made to the accompanying drawings, in which

FIG. 1 is a partial plan view of an implant according to an embodimentof the present invention.

FIG. 2A is a partial plan view of an implant according to an embodimentof the present invention.

FIG. 2B is a partial plan view of an implant according to an embodimentof the present invention.

FIG. 2C is a partial plan view of an implant according to an embodimentof the present invention.

FIG. 3 is a plan view of an implant according to an embodiment of thepresent invention.

FIG. 4 is a perspective view of an implant according to an embodiment ofthe present invention.

FIG. 5 is a cross-sectional, perspective view of one end of an implantaccording to an embodiment of the present invention.

FIG. 6 is a perspective view of an anchor according to an embodiment ofthe present invention.

FIG. 7 is a perspective view of an anchor according to an embodiment ofthe present invention.

FIG. 8A is a cross-sectional view of an anchor according to anembodiment of the present invention.

FIG. 8B is a cross-sectional view of an anchor according to anembodiment of the present invention.

FIG. 9A is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 9B is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 9C is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 9D is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 9E is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 9F is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 10A is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 10B is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 100 is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 10D is a drawing showing a process of assembling an implantaccording to an embodiment of the present invention.

FIG. 11A is a plan view of one end of an implant according to certainembodiments of the present invention.

FIG. 11B is a plan view of one end of an implant according to certainembodiments of the present invention.

FIG. 11C is a plan view of one end of an implant according to certainembodiments of the present invention.

FIG. 11D is a plan view of one end of an implant according to certainembodiments of the present invention.

FIG. 12A is a drawing showing a process of assembling an implantaccording to one embodiment of the present invention.

FIG. 12B is a drawing showing a process of assembling an implantaccording to one embodiment of the present invention.

FIG. 12C is a drawing showing a process of assembling an implantaccording to one embodiment of the present invention.

FIG. 13A is a side elevation view and a cut-away view of a deliverysystem according to an embodiment of the present invention.

FIG. 13B is a cross-sectional view of a delivery system according to anembodiment of the present invention.

FIG. 14 is a cross-sectional view of a delivery system according to anembodiment of the present invention.

FIG. 15 is a cross-sectional view of a delivery system taken alongsection line B-B of FIG. 14.

FIG. 16 is a perspective view of and implant and a delivery systemaccording to an embodiment of the present invention.

FIG. 17 is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 18A is a partial perspective view of an implant according to anembodiment of the present invention.

FIG. 18B is a partial perspective view of an implant according to anembodiment of the present invention.

FIG. 19 is a cross-sectional view of an anchor according to anembodiment of the present invention.

FIG. 20 is a perspective view of an anchor according to an embodiment ofthe present invention.

FIG. 21 is a plan view of an implant according to an embodiment of thepresent invention.

FIG. 22A is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 22B is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 23 is a perspective view of an anchor according to an embodiment ofthe present invention.

FIG. 24 is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 25 is a plan view of a locking member according to an embodiment ofthe present invention.

FIG. 26A is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 26B is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 26C is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 26D is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 27 is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 28A is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 28B is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 29 is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 30A is a plan view of an anchor according to an embodiment of thepresent invention.

FIG. 30B is a plan view of an anchor according to an embodiment of thepresent invention.

DESCRIPTION OF EMBODIMENTS

Specific embodiments of the invention will now be described withreference to the accompanying drawings. This invention may, however, beembodied in many different forms and should not be construed as limitedto the embodiments set forth herein; rather, these embodiments areprovided so that this disclosure will be thorough and complete, and willfully convey the scope of the invention to those skilled in the art. Theterminology used in the detailed description of the embodimentsillustrated in the accompanying drawings is not intended to be limitingof the invention. In the drawings, like numbers refer to like elements.

Unless otherwise defined, all terms (including technical and scientificterms) used herein have the same meaning as commonly understood by oneof ordinary skill in the art to which this invention belongs. It will befurther understood that terms, such as those defined in commonly useddictionaries, should be interpreted as having a meaning that isconsistent with their meaning in the context of the relevant art andwill not be interpreted in an idealized or overly formal sense unlessexpressly so defined herein.

The implant according to the present invention may, for example, beemployed to provide support for organs in treatment for conditions suchas incontinence and various pelvic floor disorders including but notlimited to cystocele, enterocele and recetocel. In this regard, theimplant is operative to provide a single-incision solution forimplanting a surgical support member within the body specifically forpelvic organ prolapse applications. The implant, the implant deliverysystem, and the associated methods for implanting the implant provide astrong anchor with a delivery method that is safe, fast, and easy todeploy for surgeons of various experience levels. The present inventionallows for easy and controlled deployment of an anchor deep within thebody, preferably under palpation control, while providing the ability toeasily adjust the mesh tension prior to locking the implant in place.

Broadly speaking, as shown in FIG. 1, an implant 10 according to certainembodiments of the present invention includes a supporting member 20having one or more arms 26 associated with an anchor that secures theimplant 10 to tissue within the body, e.g. the obturator member (OM),the obturator internus fascia, the obturator internus muscle, the arcustendineus levator ani, the levator ani muscle, the sacrospinousligaments (SSL), the illiococcygeus muscle, or the arcus tendineus faciapelvis (white line). For the sake of clarity, FIGS. 1-2 show only oneside of the implant 10. It is understood that the side not shown is amirror image of the side shown. FIGS. 2A-2C show alternativeconfigurations of the supporting member 20 and the arms 26. Suitablesupporting members 20 are further described in the Assignee's U.S.patent application Ser. No. 11/936,063, the contents of which are hereinincorporated by reference. In certain embodiments of the presentapplication, the supporting member 20 has a simpler shape that isapproximately rectangular, oval, or circular and in which the arms 26are less pronounced or even absent.

The support member 20 may be fabricated of a synthetic material, such assurgical mesh and the like, natural tissues, such as tissues harvestedfrom either an animal, cadaverous source or the patient himself, and/orcombinations of synthetic and natural materials. In a preferredembodiment, the support member 20 is fabricated of a mesh or weave.

In certain embodiments, a support member suture 50, shown in FIG. 16, isadvantageously attached to the support member 20. The support membersuture 50 is looped through, tied to, or otherwise associated with thesupport member 20. Preferably, the support member suture 50 is affixedto the support member 20 at a proximate mid-point of the support member20. As would be understood by one of ordinary skill in the art, it mayalso be advantageous to employ a plurality of the support member sutures50 at predetermined positions on or within the support member 20 inorder to provide a plurality of markers along a dimension of the supportmember 20. In order to distinguish the various individual sutures, thesutures may be provided in different colors, lengths, or otherindicating means that would allow a user to distinguish one suture fromanother. Indicating marks may also be provided along a length of thesuture that can be employed to determine a depth of the suture withinthe body.

Turning next to the tissue anchoring element of the implant 10 of thepresent invention. Each of the below disclosed anchors includes a tissuepiercing portion and a proximal portion having an element forassociating the anchor with the support member 20.

FIGS. 3-7 show an anchor 30 according to one embodiment of the presentinvention. The anchor 30 has a distal portion 60 and a proximal portion70 associated with one another by mid-portion 80. A proximal end of thedistal portion 60 of the anchor 30 is associated with or attached to adistal end of the mid-portion 80. Conversely, a distal end of theproximal portion 70 is associated with or attached to a proximal end ofthe mid-portion 80 of the anchor 30. The mid-portion 80 of anchor 30 isformed as a shaft or spacer that serves to provide space between thedistal portion 60 and the proximal portion 70 to, for example,accommodate a depth of tissue through which the distal portion 60 haspenetrated.

The distal portion 60 of the anchor 30 employs a piercing tip 62 forpenetrating tissue and a tissue-retention protrusion 64 proximal of thepiercing tip 60 that anchors or secures the distal portion 30 withintissue. The distal portion 60 may have, for example, an arrowhead-likeshape as shown in FIGS. 3-6. Alternatively, distal portion 60 may have amore complex shape configured to employ more than two, for example asshown in FIG. 7, four tissue-retention protrusions 64. The distalportion 60 may further employ a conical or cone-like shape having acircular tissue-retention protrusion 64. One of ordinary skill in theart would recognize that alternative shapes and configurations of thedistal portion 60 are possible while still achieving the desiredobjective. For example, distal portion 60 may employ resilient, springloaded and/or self-tensioning tissue-retention protrusions 64.

The proximal portion 70 of anchor 30 comprises a shoulder 72 forproviding a back-stop for the support member 20 and a guide member 74for engagement with a delivery system, as discussed in greater detailbelow. The proximal portion 70 may further employ recesses 76 and eyelet78. The anchor suture 40 passes through the eyelet 78 and is, forexample, secured back to itself to form a loop. The recesses 76 may bepositioned on one or both side of the eyelet 78 and configured so as toaccept the anchor suture 40 such that the presence of the anchor suture40 does not add to or change an outer dimension of the guide member 74.

The anchor 30 may be formed from a variety of materials, including butnot limited to metal alloys, such as titanium, stainless steel, orcobalt-chome alloys, polymeric materials, such as polyethylene (PE),polypropylene (PP), polysulfone, polyether ether ketone (PEEK),polyether imide (PEI), and biodegradable materials, such as polylacticacid (PLA) and polyglycolic acid (PGA) based materials. The anchor 30may be formed of a single material or a combination thereof. Forexample, as illustrated in FIGS. 8A and 8B, the anchor 30 may be formedof a combination of primary material 90, such as titanium, and abiodegradable material 92, shown in as hashed, assembled or molded overthe primary material 90.

Turning next to FIGS. 9A-9F, FIGS. 9A-9F show the steps of assemblingthe implant 10 according to various embodiments of the presentinvention. For the sake of clarity, FIGS. 9A-9F show only the assemblyof one arm 26 of the implant 10. First, a tool 90 is used to form anopening 110 through the arm 26 proximate an end of the arm 26 bypenetrating, stretching, or spreading the mesh or knitted material ofthe arm 26 of the support member 20. The tool 90 has a tapered orpointed end and a cross-section shape in the form of a circle,rectangle, oval or most any other shape. The distal portions 60 of theanchors 30 are then inserted through the openings 110 in the arm 26until the arm 26 rests against the shoulders 72 of the proximal portions72 of the anchors 30. In a preferred embodiment, the openings 110 areformed interior of the outer perimeter of the arm 26 such that there issufficient material of arm 26 so that the openings 110 do notsubstantially expand or rip though the outer perimeter of the supportmember 20.

In an alternative embodiment of the present invention, as shown in FIG.10A-10D, the shoulder of the anchor 31 is formed of a plastic or metalpin 73 that is inserted through a receiving hole 75 formed through theproximal portion of the anchor 31. During assembly of the implant 10,once the openings 110 are formed through the arm 26, the guide 74 and/orproximal portion 70 of anchor 31 is placed through the opening 110 andthe pin 73 is inserted through the receiving hole 75 to form an elementfunctionally similar to the shoulder 72 previously described. As one ofordinary skill in the art would recognize, this embodiment provides theadvantage that a smaller opening 110 may be formed when assembling theimplant 10. The smaller opening 110, in turn, provides the advantage ofthe arm 26 having a greater resistance to tearing and deformation.

In certain other embodiments of the present invention, the assembledimplant 10 as described above may be subjected to additional fabricationsteps. For instance, as shown in FIGS. 11 and 12, after insertion of theanchor 30 through the opening 110 of arm 26, a portion of the arm 26between the opening 10 and the outer perimeter of the arm 26 is foldedover the shoulder of the anchor 30 back on to itself to form a foldedportion 22. The folded portion 22 may then be bonded, sutured, welded,or tacked to it self to form bond 24 to better maintain the fold.Formation of the folded portion 22 serves, in part, to decreaseresistance to penetration of the anchor 30 into tissue. The fold 22 mayadditionally help insure that the anchor 30 remains inserted through thearm 26 during handling and implantation of the implant 10, as well asprovide a more visually appealing appearance to the implant 10. As shownin FIGS. 11 and 12, the shape of the portion of the arm 26 that formsthe fold 22 may be manipulated so as to, for example, result in the arm26 having a tapered end. A tapered end may be formed by forming aportion of the arm 26 so as to have a width that narrows at a fold line26, as shown in FIG. 11A. A tapered end may also be formed through asecondary folding of the extremities or corners of the fold 22 towardsone another, as shown in FIG. 11B. Alternatively, as shown in FIG. 11C,once the folded portion 22 is formed a suture may be threaded throughthe fold 22 and cinched and bound to itself so as to form a tapered endof the anchor 30. A tapered end may also be formed in the implant 10 bycutting or trimming the corners of the fold 22 after the fold 22 hasbeen formed, as shown in FIG. 11D.

FIGS. 12A-12C show yet another embodiment of the implant 10 in which,prior to formation of the fold 22, the arm 26 is twisted 180 degrees ormore. Again, this method of assembly decreases resistance to penetrationof the anchor and helps ensure that the anchor 30 remains insertedthrough the arm 26 during handling and implantation. One of ordinaryskill in the art will, however, recognize that other methods ofassembling the support member 20 and the anchor 30 to achieve thedesired characteristics of the implant 10 are known in the art.

Turning now to the delivery system of the present invention. Broadlyspeaking, the delivery system is configured to receive a portion of theanchor 30 of the assembled implant 10. FIG. 13A shows a delivery system120 having a handle 125 and a shaft 140. The handle 125 is preferablyergonomically shaped to facilitate grasping and manipulating. The handle125 is preferably marked, colored, textured or otherwise configured soas to indicate to a user the orientation of the delivery system 120. Theshaft 140 protrudes from or is an extension of the handle 125. The shaft125 is, for example, formed of stainless steel or other metal in thegeneral shape of a needle. A curved distal portion 142 of the shaft 140includes a cavity 144 and a slot 146.

Optionally, as shown in FIG. 13B, the delivery system 120 may furtheremploy a sheath 148. The sheath 148 is a slit tube or u-shaped channelthat functions, in part, to protect the support member 20 and variousassociated sutures from exposure to tissue during implantation. Thesheath 148 also functions to limit the depth of penetration of theanchor 30 in to the target tissue. This function is achieved byconfiguring the sheath 148 to be a distance D shorter than a length ofthe implant 10 and shaft 140 when assembled and have an outer diametergreater than that of the shaft 140 and the anchor. Because the sheath148 is displaceable along the axis of the shaft 140, arrow E of FIG.13B, the user, after first piercing the target tissue with the distalportion 60 of the anchor 30, may move the sheath to determine or measurethe approximate depth of that the anchor 30 within the target tissue.

Referring now to FIGS. 14 and 15, FIG. 14 shows the implant 10 anddelivery system 120 assembled ready for implantation of the implant 10.FIG. 15 shows a cross-sectional view of the assembled implant 10 anddelivery system 120 viewed along section line B-B of FIG. 14. As will benoted, the shape of the cavity 144 corresponds to the shape of the guide74 of the anchor 30. That is to say that the guide 74 of the anchor 30of the implant 10 and the cavity 144 of the shaft 140 of the deliverysystem 120 are complementary elements, the cavity 144 forming a femalereceiving element for the male guide 74. Preferably, the cavity 144 andthe guide 74 are formed in the shape of a square, rectangle, oval,triangle, star, or other shape that resists the guide 74 rotating withinthe cavity 144. In certain embodiments of the present invention, thecavity 144 and the guide 74 form a friction fit such that the guide 74is maintained within the cavity 144 during handling and deployment ofthe implant 10 but is readily released from the cavity 144 uponengagement of the distal portion 60 of the anchor 30 with tissue. Aportion of the slot 146 penetrates radially through the shaft 140 intothe cavity 174 and extends axially along a length of the distal portion142 of the shaft 140. Preferably, the slot 146 extends axially along theshaft 140 to a greater extent than the cavity 174. The slot 146 therebyreceives and forms a channel through which the anchor suture 40 ofanchor 30 is positioned along an axis of the shaft 140.

A method for deploying or implanting the implant 10 incorporating theanchors 30 will now be described. First, a single incision or entrypoint is made in the patient followed by blunt dissection as necessaryor desired. One side of the implant 10 incorporating the anchor 30 thatis engaged with the delivery system 120 is then inserted through theentry point and the anchor 30 that is engaged with the delivery system120 is forced into or through a portion of the target tissue, e.g. thetransobturator, the obturator internus fascia, the obturator internusmuscle, the obturator member (OM), the arcus tendineus levator ani, orlevator ani muscle. The delivery system 120 is retracted away from theanchor 30 that has penetrated the target tissue thereby breaking theengagement between the delivery system 120 and the anchor 30. Duringthis process and particularly while the delivery system 120 is beingretracted, the user secures the corresponding anchor suture 40 such thatthe delivery system 120 is retracted while an end of the anchor suture40 is maintained extending out from the entry point. The arm 26 of asecond, opposite side of the implant 10 that is engaged with thedelivery system 120 is then implanted as described with regard to thefirst side.

Substantially concurrent with the implantation of the second side of theimplant 10, the support member 20 of the implant 10 is positioned so asto support at least a portion of the desired organ. The support membersuture 50, shown in FIG. 16, may be used to determine the positionand/or tension of the implanted support member 20. The tension of thesupport member 20 spanning between the two sides of the implant 10incorporating the anchors 30 is initially adjusted by pushing thedelivery system 20 engaged with the anchor 30 of the second arms 26 ofthe implant 10 further into the target tissue. The delivery system 120is then retracted from the second arm 26 of the implant 10. An end ofthe second anchor suture 30 is also maintained such that it extends outfrom the entry point.

Should it be determined that greater tension is desired or if it isotherwise desirable to reengage of the delivery system 120 with one ofthe anchors 30, the present invention provides a particularlyadvantageous means for achieving such. As shown in FIG. 16, the end ofthe anchor suture 40 of the relevant anchor 30 that extends from theentry point is tensioned and secured. The slot 146 of the deliverysystem 120 is then positioned such that the anchor suture 40 passesthrough the slot 146, and serves as a guide for the delivery system 120to the relevant anchor 30. The delivery system 120 is advanced towardsthe relevant anchor 30 along the anchor suture 40. The guide 74 of theanchor 30 is thereby received by the cavity 144 of the delivery system120 and, if desired, the friction fit between the anchor 30 and thedelivery system 120 is reestablished. It is then possible to adjust thetension of the support member 20 of the implant 10 by pushing thedelivery system 120 so as to drive the anchor further into the targettissue. The implant can be retracted by pulling upon the suture therebyreleasing all or a portion of the tension present in the implant 10.

Upon completion of the implantation of the implant 10, the anchorsutures 40 and support member sutures 50 can be left in place forpossible use in a follow-up procedure or may be removed from thepatient.

FIGS. 17-24 show an anchor 130 according to another embodiment of thepresent invention. The anchor 130 has a distal portion 60 and a proximalportion 70 associated with one another by mid-portion 80. A proximal endof the distal portion 60 of the anchor 130 is associated with orattached to a distal end of the mid-portion 80. Conversely, a distal endof the proximal portion 70 is associated with or attached to a proximalend of the mid-portion 80 of the anchor 130. The mid-portion 80 ofanchor 130 is formed as a shaft or spacer that serves to provide spacebetween the distal portion 60 and the proximal portion 70 to, forexample, accommodate a depth of tissue through which the distal portion60 has penetrated.

The distal portion 60 of the anchor 130 employs a piercing tip 62 forpenetrating tissue and one or more tissue-retention protrusions 64proximal of the piercing tip 60 that anchor or secures the distalportion 130 within tissue. The distal portion 60 may have, for example,an arrowhead-like shape as shown in FIGS. 17-24. Alternatively, thedistal portion 60 may have a more complex shape and configuration asdescribed above, and shown in FIG. 7, regarding the anchor 30 disclosedabove.

As shown in FIG. 17, the proximal portion 70 of anchor 130 comprises anaperture 132 for receiving a portion of the support member 20, the arm26 of the support member 20, or a suture and may optionally comprise aguide member 74 for engagement with a delivery system. The guide member74 of the anchor 130 may function and be configured as described aboveregarding the anchor 30 disclosed above. Accordingly, implantation ofthe implant 10 incorporating the anchor 130 may be achievedsubstantially as described above regarding implantation of the implant10 incorporating the anchor 30. However, as will become apparent fromthe following description, the implant 10 incorporating the anchor 130,provides certain alternative methods and systems for adjusting thetension of the support member 20 spanning between two anchors 130.

The anchor 130 may be formed from a variety of materials, including butnot limited to, titanium, metal alloys, polyethylene (PE), polypropylene(PP), polysulfone, polyether ether ketone (PEEK), polyether Imide (PEI)or other suitable plastic, polymer, and biodegradable materials. Asdescribed above with respect to the anchor 30 shown in FIGS. 8A and 8B,the anchor 130 may also be formed of a single material or a combinationthereof. The overall size of the anchor 130 is approximately 1-30 mmlong and 1-25 mm wide, and preferably 5-15 mm long and 5-15 mm wide.

As shown in FIGS. 17-25, the aperture 132 of the anchor 130 may, forexample, be circular, rectangular, or ellipsoidal in shape. In certainembodiments, as shown in FIGS. 17, 18A and 18B, 22A and B, and 23, aninterior surface of the aperture 132 is substantially smooth therebyallowing the support member 20 or arm 26 to pass freely through theaperture in either direction. In such embodiments, as shown in FIGS. 18Aand 18B, the end of the support member 20 or arm 26 that passes throughthe aperture 132 is secured back to itself, to another anatomicalstructure, or a combination thereof in order to tension the implant 10.

Alternatively, as shown in FIGS. 19-21 and 24, the anchor 130 may employan aperture 132′ having teeth or other surfaces that form an engagementmember 134 that projects substantially towards an interior of theaperture 132′. As shown in FIG. 19, the engagement member 134 may beangled to one side such that the support member 20 or the arm 26 slidesfreely in the direction of the arrow 135 through the aperture 132′ butis prevented from sliding in the opposite direction due to engagementwith the angled engagement members 134. FIG. 20 shows another embodimentof the anchor 130 incorporating the engagement members 134 in which acover 136 is employed. The cover 136 is incorporated into the proximalportion 70 of the anchor 130 but attachment using a hinge or similarelement allowing the cover 136 to be opened and closed. The cover 136functions to lock the support member 20 or arm 26 into place through theaperture 132′, as well as to protect the engagement members 134 suchthat the engagement members do not become entangled with otherstructures within the body or tools used during the implantationprocedure.

FIG. 21 shows an alternative embodiment of the present invention inwhich a tube 138 and suture 139 are employed so as to further facilitateengagement and disengagement of the support member 20 or arm 26 and theengagement members 134. The suture 139 enters the aperture 132′ througha first hole 131 in the structure forming the aperture 132′ above theengagement members 134. The suture 139 then passes through the tube 138that is sized to move freely within the aperture 132′, exits the tube138, and exits the aperture 132′ through a second hole 131 in anopposite side of the structure forming the aperture 132′. The suture 139is fixed to itself so as to form a loop. An end of the suture 139 isleft to extend from the entry point.

In operation, the suture 139 is maintained without tension and thesupport member 20 or the arm 26 is passed through the aperture 132′ andtensioned such that the support member 20 or the arm 26 engages theengagement members 134 and thereby becomes locked in place. Since thesuture 139 is not tensioned, tube 138 is free to move and is pulled bythe support member 20 or the arm 26 toward and beyond the engagementmembers 134 as the support member 20 or the arm 26 engages theengagement members 134. Should it be determined that the tension of thesupport member 20 or the arm 26 needs to be adjusted the support member20 or the arm 26 are disengaged from the engagement members 134 bytensioning the suture 139 thereby lifting the support member 20 or thearm 26 off of the engagement members 134. The tension of the supportmember 20 or the arm 26 is adjusted while maintaining tension upon thesuture 139. Following adjustment of the tension of the support member 20or the arm 26, the tension on the suture 139 is released therebyreengaging the support member 20 or the arm 26 with the engagementmembers 134.

FIGS. 22A and 22B show yet another embodiment of the anchor 130 of thepresent invention in which the anchor 130 incorporates a slide lock 133having engagement members 134. The slide lock 133 is incorporated intoand integral with the anchor 130 such that the slide lock 133 slideslaterally away from and towards the aperture 132. In the open orunlocked state, shown in FIG. 22A, the slide lock 133 is withdrawn orcleared from the aperture 132 and the support member 20 or the arm 26 ispassed through the aperture 132 freely. In the locked or closed state,shown in FIG. 22B, the slide lock has been displaced so as to extendinto and/or across the aperture and thereby engage the support member 20or the arm 26 with the engagement members 134 of the slide lock 133. Inorder to maintain the slide lock in the closed state, the slide lock mayincorporate resilient portions 137 that slide into receiving elements orother structural features that prevents the slide lock from furthermovement absent disengagement of the resilient portions 137 from thereceiving elements. One of ordinary skill in the art will recognize thatthere are various known structures and configurations possible forachieving the above described embodiment, for example, the slide lockmay slide within a channel formed in proximal portion 70 of anchor 130and the resilient portions 137 may engage openings or recesses formedwithin the channel so as to lock the slide lock into a fixed position.

In certain of the embodiments, for example the embodiments shown inFIGS. 17, 18A and 18B, 22A and 22B, and 23, it is further contemplatedthat a locking or fixing of the support member 20 or the arm 26 relativeto the anchor 130 is facilitated by a separate locking member 150 asshown in FIGS. 23 and 25. The locking member 150 and aperture 132′ mayincorporate any of the above described features for engaging the supportmember 20 or the arm 26. In operation, the support member 20 or the arm26 passes through the aperture 132′ of the locking member 150. Thelocking member 150, in turn, is configured so as to resist or beincapable of passing through the aperture 132 of the anchor 130. It isalso contemplated that a suture, not shown, be attached to the lockingmember 150 in order to facilitate location and manipulation of thelocking member during the procedure.

A method for deploying or implanting the implant 10 incorporating theanchors 130 will now be described. First, a single incision or entrypoint is made in the patient followed by blunt dissection as necessaryor desired. One or more anchors 130 are delivered at various locationsin the body using the delivery system 120 described above. Sutures thatare secured to the support member 20 or the arm 26 at one end are passedthrough the aperture 132, 132′ of the anchor 130 and used to tension thesupport member 20 within the body thereby setting the support member 20in position within the body. Alternatively, the suture is omitted andthe support member 20 or the arm 26 is directly passed through theaperture 132, 132′ in order to set the support member 20 in positionwithin the body. The tension of the support member 20 spanning betweentwo corresponding anchors 132, 132′ is adjusted as described above andthe ends of the suture, the support member 20 or the arms 26 are securedso as to maintain the necessary tension. The ends of the suture, thesupport member 20 or the arm 26 are either trimmed or left in place, andthe incision is closed.

Alternatively, the anchors 130 are assembled with the support member 20prior to initiating the procedure. In such case, the step of introducinga suture, support member 10, or arm 26 through the aperture 132, 132′,after the anchor 130 has been implanted is omitted. Once the anchors 130have been implanted, the support member 20 spanning between thecorresponding anchors 130 is tensioned and adjusted as described above.

Upon completion of the implantation of the implant 10, the anchorsutures 40 and support member sutures 50 can be left in place forpossible use in a follow-up procedure or may be removed from thepatient.

FIGS. 26-30 show yet another embodiment of the present invention inwhich the anchors 160 take the form of a staple. As shown in FIG. 27,the anchors 160 comprises one or more retention loops 162 for piercingand engaging the target tissue and a tail loop 166 or associating thesupport member 20 or arm 26 with the staple 160. As shown in FIGS.26A-26D, the shape and size of the retention loops 162 may be circular,rectangular, triangular, oval or a combination thereof. The tail loop166 may also be formed in a variety of shapes and sizes. The tail loop166 may, for example, be an open of closed loop and may be shaped so asto pinch a suture, the support member 20, and/or the arm 26 of thesupport member 20. A suture or suture loop, not shown, may further beaffixed to the tail loop 166 in order to assist in assembly andimplantation of the staple 160.

FIGS. 28A and 28B show alternative embodiments of the anchor 160 inwhich a portion of the tail loop 166 passes through a hollow tube 164.FIG. 29 shows another embodiment of the present invention in which theanchor 160 is incorporated into a head 168. The head 168 may initiallyfunction to pierce the target tissue and then to assist in anchoring theanchor 160 in the target tissue. FIGS. 30A and 30B show a simplifiedembodiment of the anchor 160 employing a singular retention loop 162attached to a tail loop 166.

In operation, the anchor 160 is first retracted into a hollow piercingneedle by pulling upon the tail loop 166 such that the anchor enters thehollow piercing needle and assumes a substantially straightened, foldedconfiguration within the hollow piercing needle. The piercing needle isintroduced into the target tissue. A pusher is inserted into an oppositeend of the hollow piercing needle and used to push the anchor into thetarget tissue. The hollow piercing needle may, but need not be retractedfrom the target tissue simultaneously as the anchor 160 is pushed fromout the end of the needle. As the anchor 160 exits the needle, thestaple 160 penetrates in to the target tissue as it assume itsunconstrained shape.

After implantation of the anchor 160 within the target tissue, thesupport member 20 or arm 26 is associated with the tail loop 162 bysecuring a suture connected to the support member 20 to the tail loop162 or by directly securing the support member 20 or arm 26 to orthrough the tail loop by using any of the embodiments herein describedwith relation to the anchors 30 and 130.

The anchor 160 may be formed of a single or multi filament or wirefabricated from Nitinol, stainless steel or other metals, polymer orother shape memory material. The staple may be 1-30 mm tall and 1-30 mmwide.

A method for deploying or implanting the implant 10 incorporating theanchor 160 will now be described. First, a single incision or entrypoint is made in the patient followed by blunt dissection as necessaryor desired. One or more anchor 160 are implanted at various locationswithin the body. Sutures that are passed through the tail loop 162 andsecured to the support member 20 or the arm 26 at one end are used totension the support member 20 within the body. Alternatively, thesupport member 20 or the arm 26 is directly passed through the tail loop162 of the anchor 160 in order to set the support member 160 in positionwithin the body. The support member 20 tension is adjusted as desired.The ends of the suture, the support member 20 or the arms 26 are securedso as to maintain the necessary tension and trimmed as desired and theincision is closed.

The implants 10 according to the present invention may employ theanchors 30, 130, or 160 exclusively or, as shown in FIGS. 1 and 2C, mayemploy a combination of different types of anchors. For example, FIGS. 1and 2C shows a portion of the implant 10 that employs the anchors 30 ona first set of arms 26 and the anchors 130 on a second set of arms 26.During implantation, the anchors 30 incorporated into the first set ofarms 26 are first implanted in or through the transobturator, and theanchors 130 incorporated into the second set of arms 26 are nextimplanted in or through the sacrospinous ligaments, SSL. It will beunderstood by one of skill in the art the different anchors of thepresent invention will each lend themselves to implantation withinpotentially different target tissues having different characteristicsand locations within the body.

While the present invention has been described for use in treatingpelvic floor disorders and incontinence, it would be understood by oneof skill in the art that the present invention can be used support otherorgans within the body or as a means of fixation of tissue or implantswithin the body.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

What is claimed is:
 1. A method for supporting an anatomical structurecomprising: (a) making an entry point in a body of a patient; (b)engaging a first anchor with a delivery system and inserting the firstanchor through the entry point and into a target tissue of the body; (c)retracting the delivery system from the first anchor and out from theentry point; (d) reengaging the delivery system with the first anchor bypassing a suture extending from the first anchor and out the entry pointthrough a slot in the delivery system and advancing the delivery systemtowards the first anchor until the first anchor is received by thedelivery system; (e) adjusting a position of the first anchor in thetarget tissue with the delivery system and retracting the deliverysystem from the first anchor and out from the entry point after saidadjusting; (f) positioning a support member between the first anchor anda second anchor secured within said body; (g) locking said supportmember in position relative to the first and second anchors by passing amesh portion of the support member through an aperture of one of thefirst and second anchors and engaging said mesh portion of said supportmember with projections extending from an interior of the aperture; and(h) closing said entry point.